Pa. Judge Won’t Strike Actos Verdict Against Takeda

Pennsylvania judge has declined to overturn a $2 million verdict awarded in October to a plaintiff who claimed that the Takeda Pharmaceuticals Inc. drug Actos was a significant contributor to her developing bladder cancer.

In an order docketed on Friday, Philadelphia Court of Common Pleas Judge Shelly Robins New rejected the company’s post-trial motions, in which they had argued that the jury’s verdict overstepped the U.S. Food and Drug Administration’s authority.

The judge also added nearly $100,000 in delay damages, leading to a total judgment of $2.14 million for plaintiff Frances Wisniewski.

Wisniewski filed suit in the Philadelphia County Court of Common Pleas in July 2012, alleging that she developed tumors in her bladder during a seven-year course of treatment on the drug. A trial in the case began in early September, according to court records.

According to the FDA, the drug’s label was updated in August 2011 to include a warning that use of Actos for more than one year may be associated with an increased risk of bladder cancer. Wisniewski’s attorneys said that her physician took her off of the drug soon after the updated warning was issued.

On Oct. 3, the jury returned a verdict finding that Actos had substantially contributed to Wisniewski’s bladder cancer and awarded her $2,050,000 in damages.

But in a motion filed later that month, Takeda argued that Wisniewski’s claim was preempted by the FDA’s authority to dictate warning labels, adding that she had failed to clear the evidentiary bar required to prove that Actos had been the substantial cause of her bladder cancer.

Defense witnesses claimed that Wisniewski had several other major risk factors, including a history of smoking and excess weight, each of which could be pegged as the substantial cause of her bladder cancer.

In the alternative, the company argued that it should be afforded a new trial due to errors in the judge’s charging statement to the jury. Takeda said that the charge had been improperly based on New York law instead of Pennsylvania law.

“We are disappointed with the ruling and intend to pursue available legal remedies, including an appeal,” the company said on Monday.

Takeda is in the final stages of a second product liability trial over Actos in Philadelphia. The company is presenting its defense to Butler County resident John Kristufek’s claims that the drug also caused his bladder cancer. Closing arguments are anticipated on Wednesday.

Wisniewski is represented by Michael Miller of the Miller Firm LLC.

Takeda is represented by Craig Thompson of Venable LLP and by Robert Limbacher, Eben Flaster and Shevon Rockett of Goodell DeVries Leech & Dann LLP.

The case is Frances Wisniewski v. Takeda Pharmaceuticals America Inc. et al., case number 120702272, in the Philadelphia County Court of Common Pleas.